Gestational Diabetes Mellitus Clinical Trial
Official title:
Effects of Medical Nutrition Therapy Combined With TPF-DM in Pregnant Women With Gestational Diabetes Mellitus on Blood Glucose Fluctuations and Pregnancy Outcomes
Verified date | March 2024 |
Source | Capital Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Background: Gestational diabetes mellitus (GDM), GDM is the first time of gestational impaired glucose tolerance in pregnant women. It is the most common complication disease in women of childbearing age. It is associated with the high risk of adverse health outcomes for both mothers and offsprings and the variety of metabolic disease, including type 2 diabetes, etc. As for the epidemiology data of GDM in China, the prevalence is around 18% based on the criteria from the International Association of Diabetes in Pregnancy Study Groups, IADPSG. Several studies claimed that the diabetes-specific formula improved glycemic control in type 2 diabetes patients. However, the effects of medical nutrition therapy combined with the diabetes-specific formula in pregnant women with gestational diabetes mellitus (GDM) are unclear. Objective: This study examines whether medical nutrition therapy combined with Enteral Nutrition Suspension (TFP-DM, Diason 0.75 kcal/ml) in GDM women could improve the glycemic control and the pregnancy outcomes.
Status | Completed |
Enrollment | 100 |
Est. completion date | December 31, 2023 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility | Inclusion Criteria: - Gestational age between 24 and 28 weeks of gestation - Age >= 18 years - Singleton pregnancy - Two of three or three results of the oral glucose tolerance test (OGTT) are above the diagnostic criteria. (The diagnostic criteria for three results of OGTT: Fasting plasma glucose = 5.1mmol/L, 1-hour OGTT plasma glucose = 10.0mmol/L, 2-hour OGTT plasma glucose = 8.5mmol/L) Exclusion Criteria: - History of prenatal hypertension, diabetes, hyperlipidemias, liver disease, kidney disease, digestive tract disease and infectious disease (hepatitis, tuberculosis etc.) - Gestational weeks < 24 or > 28 - Age < 18 years or Age > 45 years - Multiple pregnancy - Food allergic history - Regular smoking, drinking alcohol - Patients with the history of using the assisted reproductive technology - Patients with psychiatric disorders that prevents correctly answer the questions - Patients who are unable to answer the questionnaire questions - Bariatric surgery history - Non-adherence of dietary and lifestyle recommendation - Threatened abortion |
Country | Name | City | State |
---|---|---|---|
China | Beijing Obstetrics and Gynecology Hospital,Capital Medical University | Beijing |
Lead Sponsor | Collaborator |
---|---|
Capital Medical University | Nutricia Pharmaceutical Co., Ltd., Zhejiang University School of Medicine, Obstetrics and Gynecology Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in HbA1c from Baseline at 2 months | Gestational age 24-28 weeks and 32-34 weeks and 36-40 weeks and 42-70 days after delivery | ||
Primary | Insulin treatmeant ratio | From enrollment to delivery | ||
Primary | Change in serum glycated albumin from Baseline at 2 months | Gestational age 24-28weeks and 32-34weeks and 36-40 weeks and 42-70days after delivery | ||
Primary | Change in fasting blood glucose concentration from Baseline at 2 months | Gestational age 24-28 weeks and 32-34 weeks and 36-40 weeks and 42-70 days after delivery | ||
Primary | Change in Fasting insulin concentration from Baseline at 2 months | Gestational age 24-28 weeks and 32-34 weeks and 36-40 weeks and 42-70 days after delivery | ||
Secondary | Oral glucose tolerance test | Gestational age 24-28 weeks and 42-70 days after delivery | ||
Secondary | The insulin sensitivity (HOMA-IS) | From enrollment to the 42 days after delivery | ||
Secondary | Gestational weight gain | From enrollment to the 42 days after delivery | ||
Secondary | The incidence of macrosomia infants | From enrollment to delivery |
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